Emergent BioSolutions Inc. (NYSE:EBS) announced today that late on April
15th, HHS requested that each bidder in the competitive range
for the rPA contract submit its product development plans to FDA for
review in advance of an award. Emergent had already requested and is
presently scheduling a meeting with the FDA as part of its pre-award
activity. The Company intends to incorporate any FDA comments into its
rPA development plan. Emergent will continue to move its rPA program
forward to position the company to execute on the anticipated contract,
once awarded.
"We strongly support this step by HHS, which potentially reduces
development risk for our rPA vaccine candidate. We remain confident that
we are well-positioned and competitive to receive any award granted by
HHS for the development and procurement of the rPA vaccine. We look
forward to continuing our long-standing relationship with the US
Government as the proven and preeminent supplier of medical
countermeasures to protect our nation,” said Fuad El-Hibri, chairman and
chief executive officer of Emergent BioSolutions.
As with any government solicitation of this size and scope, there are no
assurances that HHS will not impose additional requirements, which may
further extend contract negotiations.
This action has no impact on the company’s existing contracts with HHS
to supply BioThrax®, the only FDA licensed anthrax vaccine, for the
Strategic National Stockpile (SNS). This year Emergent is completing the
delivery of 18.75 million doses of BioThrax for inclusion in the SNS.
Also this year, following the completion of that delivery, Emergent will
begin to supply HHS with an additional 14.5 million doses of BioThrax
under a follow-on contract. The total value of these two procurement
contracts with HHS for BioThrax exceeds $800 million.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of vaccines and
therapeutics that assist the body’s immune system to prevent or treat
disease. Emergent’s marketed product, BioThrax® (Anthrax
Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and
Drug Administration for the prevention of anthrax. Emergent’s
development pipeline includes programs focused on anthrax, botulism,
tuberculosis, typhoid, hepatitis B and chlamydia. Additional information
may be found at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management, including any potential future securities
offering, and any other statements containing the words "believes,”
"expects,” "anticipates,” "plans,” "estimates” and similar expressions,
are forward-looking statements. There are a number of important factors
that could cause the company's actual results to differ materially from
those indicated by such forward-looking statements, including the
success of our clinical programs; our plans to expand our manufacturing
facilities and capabilities; the rate and degree of market acceptance
and clinical utility of our products; the timing of and our ability to
obtain and maintain regulatory approvals for our other product
candidates; our commercialization, marketing and manufacturing
capabilities and strategy; our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing; and
other factors identified in the company's annual report on Form 10-K for
the year ended December 31, 2008 and subsequent reports filed with the
SEC. The company disclaims any intention or obligation to update any
forward-looking statements as a result of developments occurring after
the date of this press release.
